UA107186C2 - SOLID FORMS OF BENDAMUSTINE DOSAGE - Google Patents
SOLID FORMS OF BENDAMUSTINE DOSAGEInfo
- Publication number
- UA107186C2 UA107186C2 UAA201106236A UAA201106236A UA107186C2 UA 107186 C2 UA107186 C2 UA 107186C2 UA A201106236 A UAA201106236 A UA A201106236A UA A201106236 A UAA201106236 A UA A201106236A UA 107186 C2 UA107186 C2 UA 107186C2
- Authority
- UA
- Ukraine
- Prior art keywords
- pharmaceutically acceptable
- saccharide
- polysaccharide
- tablets
- disaccharide
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/243—Platinum; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
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- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A61P35/00—Antineoplastic agents
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Transplantation (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Винахід стосується фармацевтичної композиції у твердій формі дозування для перорального призначення, яка містить як активний інгредієнт бендамустин або його фармацевтично прийнятний естер, сіль або сольват та принаймні один фармацевтично прийнятний наповнювач, яким є фармацевтично прийнятний сахарид, вибраний з одного або більше: моносахариду, дисахариду, олігосахариду, циклічного олігосахариду, полісахариду та сахаридного спирту, де співвідношення мас активного інгредієнта відносно сахаридного наповнювача є у межах 1:1-5, та в якому композиція є у формі таблеток, гранулятів або пігулок, та де полісахарид не є мікрокристалічною целюлозою, якщо сахаридний спирт є тільки манітолом.The invention relates to a pharmaceutical composition in solid dosage form for oral administration containing as an active ingredient bendamustine or its pharmaceutically acceptable ester, salt or solvate and at least one pharmaceutically acceptable excipient, which is a pharmaceutically acceptable saccharide selected from one or more: monosaccharide, disaccharide, disaccharide oligosaccharide, cyclic oligosaccharide, polysaccharide and saccharide alcohol, where the mass ratio of the active ingredient to the saccharide filler is in the range 1: 1-5, and in which ompozytsiya is in the form of tablets, granules or tablets, and where the polysaccharide is not microcrystalline cellulose, if only Carbohydrate alcohol is mannitol.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
UAA201404416A UA116334C2 (en) | 2008-12-03 | 2009-12-03 | SOLID FORMS OF BENDAMUSTINE DOSAGE |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08020996 | 2008-12-03 | ||
PCT/EP2009/008639 WO2010063476A2 (en) | 2008-12-03 | 2009-12-03 | Solid dosage forms of bendamustine |
Publications (1)
Publication Number | Publication Date |
---|---|
UA107186C2 true UA107186C2 (en) | 2014-12-10 |
Family
ID=40588072
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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UAA201106236A UA107186C2 (en) | 2008-12-03 | 2009-03-12 | SOLID FORMS OF BENDAMUSTINE DOSAGE |
UAA201404416A UA116334C2 (en) | 2008-12-03 | 2009-12-03 | SOLID FORMS OF BENDAMUSTINE DOSAGE |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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UAA201404416A UA116334C2 (en) | 2008-12-03 | 2009-12-03 | SOLID FORMS OF BENDAMUSTINE DOSAGE |
Country Status (26)
Country | Link |
---|---|
US (4) | US20120003309A1 (en) |
EP (1) | EP2367538B1 (en) |
JP (3) | JP5658679B2 (en) |
KR (1) | KR101710935B1 (en) |
CN (2) | CN107080742B (en) |
AU (1) | AU2009321728B2 (en) |
BR (1) | BRPI0922804B8 (en) |
CA (1) | CA2745509A1 (en) |
CO (1) | CO6400185A2 (en) |
CY (1) | CY1119839T1 (en) |
DK (1) | DK2367538T3 (en) |
EA (1) | EA028179B1 (en) |
ES (1) | ES2645008T3 (en) |
HR (1) | HRP20171421T1 (en) |
HU (1) | HUE036481T2 (en) |
IL (1) | IL213269A (en) |
LT (1) | LT2367538T (en) |
MX (1) | MX2011005633A (en) |
NZ (1) | NZ592971A (en) |
PL (1) | PL2367538T3 (en) |
PT (1) | PT2367538T (en) |
RS (1) | RS56408B1 (en) |
SI (1) | SI2367538T1 (en) |
UA (2) | UA107186C2 (en) |
WO (1) | WO2010063476A2 (en) |
ZA (1) | ZA201103790B (en) |
Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
UA107186C2 (en) * | 2008-12-03 | 2014-12-10 | SOLID FORMS OF BENDAMUSTINE DOSAGE | |
MY173873A (en) * | 2010-06-02 | 2020-02-25 | Astellas Deutschland Gmbh | Oral dosage forms of bendamustine |
JO3659B1 (en) * | 2010-06-02 | 2020-08-27 | Astellas Deutschland Gmbh | Oral dosage forms of bendamustine and therapeutic use thereof |
CN102375044B (en) * | 2010-08-18 | 2015-04-08 | 重庆华邦胜凯制药有限公司 | Method for analyzing related substance from hydrochloric acid bendamustine intermediate Z6 |
EP2641592A1 (en) | 2012-03-23 | 2013-09-25 | Salmon Pharma GmbH | Pharmaceutical formulation comprising bendamustine |
JP2016153374A (en) * | 2013-06-25 | 2016-08-25 | シンバイオ製薬株式会社 | Pharmaceutical composition for treating or preventing inflammatory disease |
CA2922099C (en) | 2013-08-27 | 2022-11-29 | Vasilios VOUDOURIS | Bendamustine pharmaceutical compositions |
CN105566226B (en) * | 2014-05-06 | 2019-06-21 | 南京先声东元制药有限公司 | The preparation method and application of bendamustine hydrochloride dimer |
JP6608193B2 (en) * | 2014-06-27 | 2019-11-20 | 花王株式会社 | Solid composition |
WO2016005995A2 (en) * | 2014-07-10 | 2016-01-14 | Leiutis Pharmaceuticals Pvt. Ltd. | Glycol free stable liquid compositions of bendamustine |
JP5897196B1 (en) * | 2015-10-05 | 2016-03-30 | 大同化成工業株式会社 | Compound granulated product containing sugar or sugar alcohol, swelling binder, disintegrant and superabsorbent excipient, and production method thereof |
EP3691637A1 (en) | 2017-10-05 | 2020-08-12 | TUBE Pharmaceuticals GmbH | Oral bendamustine formulations |
CN110437261A (en) * | 2018-05-02 | 2019-11-12 | 南京诺瑞特医药科技有限公司 | The synthetic method of bendamustine impurity G |
CN113768038A (en) * | 2021-09-14 | 2021-12-10 | 江苏省协同医药生物工程有限责任公司 | Accurate quantitative experimental animal functional feed and preparation method and equipment |
CN117257913B (en) * | 2023-11-23 | 2024-01-26 | 江西中医药大学附属医院 | Lung-warming chemical fiber granule and preparation method thereof |
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MY191349A (en) * | 2004-08-27 | 2022-06-17 | Bayer Pharmaceuticals Corp | New pharmaceutical compositions for the treatment of hyper-proliferative disorders |
CA2585659A1 (en) * | 2004-11-05 | 2006-06-22 | Cephalon, Inc. | Cancer treatments |
US8436190B2 (en) * | 2005-01-14 | 2013-05-07 | Cephalon, Inc. | Bendamustine pharmaceutical compositions |
AR072777A1 (en) * | 2008-03-26 | 2010-09-22 | Cephalon Inc | SOLID FORMS OF BENDAMUSTINE CHLORHYDRATE |
UA107186C2 (en) * | 2008-12-03 | 2014-12-10 | SOLID FORMS OF BENDAMUSTINE DOSAGE |
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